Contract manufacturerNOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS (Billerica, MA)MassachusettsClinical chemistryClass IIClass I
NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
Contract manufacturer · Billerica, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3004193489 (openFDA record; or search FDA's registration database)
- FEI number
- 3004193489
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Manufacturer for export only; Manufacturer; Contract manufacturer; Remanufacturer
- Owner or operator
- NOVA BIOMEDICAL CORP. (FDA owner/operator no. 1219029)
- Registered address
- 39 Manning Rd, Billerica, MA 01821
- Contract listings
- 15 device listings, 9 product codes, first listed Oct 19, 2007
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | Class II | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | Class II | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Class I | Clinical chemistry | Contract manufacturing | Nov 26, 2010 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | Clinical chemistry | Contract manufacturing | Jul 17, 2013 |
| LFR | Glucose Dehydrogenase, Glucose | Class II | Clinical chemistry | Contract manufacturing | May 1, 2012 |
| NBW | System, Test, Blood Glucose, Over The Counter | Class II | Clinical chemistry | Contract manufacturing | Oct 19, 2007 |
| PTC | Uric Acid Test System For At Home Prescription Use | Class I | Clinical chemistry | Contract manufacturing | May 11, 2017 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | Class II | Clinical chemistry | Contract manufacturing | Jan 15, 2015 |